Ceramic Implant, Tooth Loss
Conditions
Keywords
zirconia implant, zirconium oxide implant, dental implant, ceramic implant, CeraRoot, one-piece, monotype
Brief summary
The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.
Detailed description
Traditionally the material of choice for dental implants has been titanium. The success of such material has been unquestionable for the last decades. However a number of issues arise lately regarding the biocompatibility or cytotoxicity or allergies regarding the degradation or oxidation particles within the bone or gum. Esthetics has been a concern as well specially in patients with thin biotype where the metal may produce a grayish look of the mucosa. For this reason the dental community and patients have raised much interest in ceramic dental implants as a tooth colored and metal free alternative for dental implants. Since 2006 CeraRoot ceramic implants have been available in the market. The reason for designing this PMCF is to evaluate the long term success of CeraRoot ceramic implants To achieve those objectives an observational study of patients that have received such implant is designed, using marginal bone loss as a primary response variable. It is estimated that a sample size 200 patients over the 3 year period is needed to achieve relevant data.
Interventions
None listed
Sponsors
CeraRoot SL
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients that have received the studied ceramic implant after 27 August 2020. * Patients of CeraRoot Clinic (Barcelona) * Age \>18 * Single or multiple missing or hopeless teeth
Exclusion criteria
* Smokers. * The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs). * Untreated periodontal conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Implants That Survived | Baseline to 3 years | Implant without pain, without mobility and in function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Implants With Surgical Complications (SC) | Baseline to 7 days | Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected |
| Number of Implants With Before Loading Implants Complications (BLIC) | 7 days post operative to delivery of prosthesis | Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected |
| Number of Implants With After Loading Implants Complications (ALIC) | From delivery of prosthesis to two years later. | Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded. |
| Number of Units With Prosthetic Complications (PC) | Baseline to 3 years | Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered. |
Countries
Spain
Participant flow
Recruitment details
Participants were included if received a CeraRoot implant between August 27th 2020 and December 4th 2023, provided the inclusion criteria were met.
Pre-assignment details
98 patients with a total of 175 implants met the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| CeraRoot Implant CeraRoot ceramic dental implant one-piece | 98 |
| CeraRoot Implant CeraRoot ceramic dental implant one-piece | 175 |
| Total | 273 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol Violation | 5 |
Baseline characteristics
| Characteristic | CeraRoot Implant |
|---|---|
| Age, Customized 21-40 | 14 Participants |
| Age, Customized 41-60 | 54 Participants |
| Age, Customized 61-80 | 28 Participants |
| Age, Customized Age <21 | 2 Participants |
| Region of Enrollment Spain | 98 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 98 |
| other Total, other adverse events | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 |
Outcome results
Primary
Number of Implants That Survived
Implant without pain, without mobility and in function.
Time frame: Baseline to 3 years
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CeraRoot Implants | Number of Implants That Survived | SUCCESS | 157 implants |
| CeraRoot Implants | Number of Implants That Survived | FAILURE | 5 implants |
Secondary
Number of Implants With After Loading Implants Complications (ALIC)
Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded.
Time frame: From delivery of prosthesis to two years later.
Population: Patients that received CeraRoot implants and were not excluded from the study.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CeraRoot Implants | Number of Implants With After Loading Implants Complications (ALIC) | Sinus Infection | 1 implants |
| CeraRoot Implants | Number of Implants With After Loading Implants Complications (ALIC) | Occlusal premature contact | 1 implants |
| CeraRoot Implants | Number of Implants With After Loading Implants Complications (ALIC) | Premature Loading | 2 implants |
| CeraRoot Implants | Number of Implants With After Loading Implants Complications (ALIC) | Aseptic Losening | 1 implants |
Secondary
Number of Implants With Before Loading Implants Complications (BLIC)
Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected
Time frame: 7 days post operative to delivery of prosthesis
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CeraRoot Implants | Number of Implants With Before Loading Implants Complications (BLIC) | 0 implants |
Secondary
Number of Implants With Surgical Complications (SC)
Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected
Time frame: Baseline to 7 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CeraRoot Implants | Number of Implants With Surgical Complications (SC) | 0 implants |
Secondary
Number of Units With Prosthetic Complications (PC)
Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered.
Time frame: Baseline to 3 years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CeraRoot Implants | Number of Units With Prosthetic Complications (PC) | 0 implants |